EUCTR2011-002159-32-IT进行中（未招募）不适用
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of BIIB023 in Subjects With Lupus Nephritis - ATLAS
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations.
- •Aged 18 to 75 years old, inclusive, at the time of informed consent.
- •Must have a documented diagnosis of SLE according to current ACR criteria. At least 4 ACR criteria must be documented, 1 of which must be a positive antinuclear antibody (ANA), anti-Sm, or anti-dsDNA antibody.
- •Must have a diagnosis of ISN/RPS 2003 Class III or IV LN with either active or active/chronic disease, confirmed by biopsy within 3 months prior to Screening. Subjects are permitted to have co-existing Class V LN. The local histological diagnosis must be confirmed by the central study pathologist.
- •Must have proteinuria at Screening (from a 24-hour urine sample collection) defined as: uPCR >1.0 in subjects with biopsy Class III or IV LN uPCR >2.0 in subjects with co-existing Class V LN
- •Subjects of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 3 months after their last dose of study treatment.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 285
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 15
排除标准
- •Retinitis, poorly-controlled seizure disorder, acute confusional state, myelitis, stroke or stroke syndrome, cerebellar ataxia, or dementia that is currently active and resulting from SLE at Screening
- •Estimated GFR <30 mL/min per 1.73 m2 (calculated using the abbreviated MDRD equation) or the presence of oliguria or ESRD requiring dialysis or transplantation
- •Subjects requiring dialysis within 12 months prior to Screening
- •History of renal transplant
- •History of opportunistic infection within 3 years of Screening.
- •Subjects with the following abnormal laboratory test result at Screening considered clinically significant (as determined by the Investigator) or: AST/SGOT or ALT/SGPT >2 x upper limit of normal established by the central laboratory; platelet count <20,000/µL; subjects with platelet count >20,000/µL and <150,000 who are experiencing, or at high risk for developing, clinically significant bleeding or organ dysfunction requiring therapy (as determined by the Investigator) should be excluded from the study; hemoglobin <8.5 g/dL; neutrophils <1.5 x 103/µL
- •Receipt of >1.5 g IV methylprednisolone (cumulative dose) within 28 days prior to Screening
- •Use of >30 mg/day oral prednisone or equivalent for >14 consecutive days within 4 weeks prior to Screening
- •Treatment with any biologic B-cell-depleting therapy (e.g., anti-CD20 [rituximab], anti-CD22 [epratuzumab], anti-BLyS/BAFF [e.g., briobacept, belimumab] therapy), or TACI-Ig within 12 months prior to Run-in Day 1.
研究者
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